Argon Medical Issues Class I Recall for Kits with Huons Lidocaine

Argon Medical has issued a Class I recall, the most serious type, for specific convenience kits containing Spectra Medical Device Lidocaine Ampules due to components affected by a prior Huons Co., Ltd. recall.

The recall involves correcting devices by removing affected components, rather than removing them from use or sale. The FDA emphasized, "This device may cause serious injury or death if you continue to use it without correction."

The issue stems from Huons Co., Ltd.'s recall of Bupivacaine HCL in Dextrose Injection, USP, which carries risks including infection, inflammatory response, and reduced anesthetic effectiveness. When used in the neuraxial space, there is a risk of cerebral fluid contamination and meningitis that may progress to encephalitis.

As of June 1, Argon Medical has reported two serious injuries and no deaths related to this issue. Customers in the U.S. with questions or adverse reactions should contact Argon Medical at quality.regulatory@argonmedical.com.